Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).
Totally 160 health people aged 3-59 years old will be divided into two age group, containing 80 in 18-59 years old and 80 in 3-19 years old. All subjects will receive vaccination either LAVI or placebo in a ratio of 3:1.
All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation.
All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.
Condition | Influenza Prevention |
---|---|
Treatment | Live Attenuated Influenza Vaccine, Live Attenuated Influenza Vaccine, Live Attenuated Influenza Vaccine placebo |
Clinical Study Identifier | NCT05056519 |
Sponsor | Changchun BCHT Biotechnology Co. |
Last Modified on | 28 May 2022 |
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